gmp clean abcd grading standards are as follows:
Class A: high-risk operation area, such as: filling area, placing the cork barrels, open ampoule, open vials of vials, and aseptic assembly or connection operation area. Laminar flow benches (hoods) are usually used to maintain the environmental status of the area. Laminar flow system in its working area must be uniform air supply, air velocity of 0.36-0.54m/s (guide value).
Data should be available to demonstrate the status of laminar flow and must be verified. Unidirectional flow or lower air velocities may be used in closed isolation manipulators or glove boxes.Class B: The background area in which high-risk operations, such as aseptic preparation and filling, are located in the Class A area.Class C and D: Clean operation areas of lower importance in the production of aseptic pharmaceutical products.
Introduction of GMP:
The goal of GMP is to ensure the establishment of a scientific and rigorous environment, process, operation and management system for the production of aseptic pharmaceuticals, to maximize the elimination of all possible and potential biologically active, dust and pyrogenic contamination, and to produce high quality, hygienic and safe pharmaceutical products. What we call biopharmaceutical purification engineering - GMP clean plant engineering solutions and pollution control technology is to ensure the successful implementation of GMP one of the main means.
Biological aseptic production plant, the building is 121x18 meters, *** three-story reinforced concrete structure plant, single-story area of 2,268 M2. the first phase of the production plant is located in the west of the first floor, the building is 5 meters, the bottom of the beam height of 4.2 meters; which is designed for injection molding area of the workshop ceiling height of 3.0 meters, and the other areas of 2.6 meters; raw materials crushing, dosage room for 2.4 meters. It mainly produces sterile medical disposable apparatus. Designed for 100,000 level domain + air-conditioned area.
Summary:
The goal of GMP required by biopharmaceutical companies is to ensure the establishment of a scientific and rigorous environment, process, operation and management system for sterile drug production, to maximize the elimination of all possible and potential biological activity, dust, pyrogenic contamination, and to produce high-quality, hygienic and safe drug products.
What we call biopharmaceutical purification engineering-GMP clean plant engineering solutions and pollution control technology is to ensure the successful implementation of GMP one of the main means; through the biopharmaceutical customer production environment in-depth study and accumulation of engineering experience, we clearly understand the key to environmental control of the biopharmaceutical production process; energy saving is the focus of the priority of our system solutions.
What we do best is to give our customers to meet the requirements of GMP and Fed209D, ISO14644, IEST, EN1822 international standards, and at the same time apply the latest energy-saving technology of the environmental solutions; we can provide from the GMP whole plant planning and design - human flow and logistics purification program, Clean air-conditioning system, clean decoration system; whole plant energy-saving transformation, water and electricity, ultra-pure gas pipeline, clean room monitoring, maintenance systems and other comprehensive installation support services.